Ignite Creation Date:
2024-05-06 @ 9:26 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02987127
Status:
UNKNOWN
Last Update Posted:
2016-12-08
First Post:
2016-12-01
Brief Title:
Prospective Study of Frontline H Pylori Eradication in the Treatment of Early-stage Extragastric MALT Lymphoma
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Prospective Study of Frontline Helicobacter Pylori Eradication Therapy in the Treatment of Early-stage Extragastric Mucosa-associated Lymphoid Tissue Lymphoma
Status:
UNKNOWN
Status Verified Date:
2016-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Gastric low-grade mucosa-associated lymphoid tissue lymphoma MALToma is associated with Helicobacter pylori HP infection and around 70 of these tumors can be cured by HP eradication therapy HPE However the role of antibiotics in the frontline treatment of extragastric MALToma remains unclear In addition to anecdotal case reports showing histologic regression of extragastric MALTomas after antibiotics our explorative study found that frontline HPE clarithromycin amoxicillin and omeprazole resulted in complete remission CR in this subgroup patients 2 salivary gland 1 lung 1 colon and 4 ocular adnexal MALToma OAML Interestingly two patients with OAML who do not respond to Chlamydia psittaci CP eradication using doxycycline achieved CR after HPE These findings suggest that bacterial infections including HP may be involved in the lymphomagenesis of these extragastric MALTomas Our preliminary results also revealed that 5 238 of 21 HP-negative gastric MALToma patients achieved CR after HPE indicating that antibiotics may also have ability to eradicate non-HP bacteria Based on our preliminary findings and the indolent biologic behavior of MALToma it is reasonable to use frontline HPE in the treatment of early-stage low-grade extragastric MALToma
Detailed Description:
Through a prospective trial of frontline HPE in the treatment of early-stage extragastric MALToma investigators will evaluate and investigate the following issues
1 The CR and partial remission PR rate for antibiotics as 1st-line therapy for stage IE and stage IIE extragastric MALToma
2 The durability of CR and PR relapse-free survival after antibiotics treatment HPE in early-stage extragastric MALToma
3 The assessment of the evidence of bacterial infection such as HP in extragastric MALToma
4 The identification of potential biomarkers that help us predict whether extragastric MALToma can respond to frontline HPE
1 The CR and partial remission PR rate for antibiotics as 1st-line therapy for stage IE and stage IIE extragastric MALToma
2 The durability of CR and PR relapse-free survival after antibiotics treatment HPE in early-stage extragastric MALToma
3 The assessment of the evidence of bacterial infection such as HP in extragastric MALToma
4 The identification of potential biomarkers that help us predict whether extragastric MALToma can respond to frontline HPE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None